Good afternoon or good morning. Welcome to XVIVO Capital Markets Day 2022. Last year, we held our first Capital Markets Day here in Gothenburg, and this year we have chosen a 100% digital format for the two hours which we will be spending together. We have more than 100 listeners this year versus 80 last year, so welcome all of you. Please remember that the Q&A session will be at the end of the presentations, so note down any questions you might have.
The agenda has been communicated, and we will give you an insight into the key components of our strategy and also some short to mid-term actions. I have promised more quantitative insights into what we expect to deliver by 2027 compared with what we presented at last year's Capital Markets Day, and you will get some more quantitative insights.
Let's get started. For those of you who have limited knowledge about XVIVO and our industry, XVIVO operates in the field of transplantation, and our core business is within organ recovery, organ preservation, and organ evaluation for donor organs outside the body. We have three business areas, machines and solutions for the thoracic organs, meaning heart and lung. Machines for the abdominal organs, meaning kidney and liver, and services, meaning organ recovery and logistics. Nearly 60% of our sales derive from North America, 35% from Europe, Middle East and Africa, and 5% from Asia Pacific. Head office here in Gothenburg and listed on Nasdaq Mid Cap. The challenge in transplantation remains the same. The need for new organs continues to be many times higher than the actual number of organs transplanted.
The major issue in transplantation today is actually the inability to use or utilize many organs. The issue is particularly serious when it comes to thoracic organs, lung and heart, where 70%-80% of the organs are discarded when traditional methods for preserving organs are used. There are some limiting factors in facing our industry, and we have developed a product and service offering which addresses all these critical issues. Starting with organ quality, our machines, meaning Liver Assist, the XPS for lungs, Kidney Assist Transport, enable more organs to be used through unique perfusion technology.
When it comes to capacity, we as a company offer services through STAR Teams and Avionord, our latest acquisitions, to support clinics which face resource constraints when it comes to recovery and/or perfusing organs. When it comes to logistics, limitations of organ out-of-body time creates constraints.
Our machines, notably the Kidney Assist Transport and heart device, enable increased out-of-body time. In summary, XVIVO enables safe use of more organs. Let us now pay a one-minute visit to Fredrika Höglund, a young woman who recently received a new liver here in Gothenburg. Our purpose is we believe in an extended life for organs. Nobody should die waiting for a new organ. Let us now listen to Fredrika's story.
I got a new liver, and that gave me the chance to see my children grow up. In my early twenties, I had developed PSC and would need a liver transplant at some point in my life. I had no symptoms until I was 28 years old, and then I gradually became worse after each of my two pregnancies. My eyes and skin turned yellow, and the soles of my feet and palms were constantly itching.
I continued to be sick on and off, but lived a full life. We went skiing, I ran three half marathons, and we had a rich social life. In May 2016, I was listed on the waiting list. After nine months, I had almost given up, but then I got the call. They wanted me to come in the same evening and everything just felt so surreal.
One of the hardest things I have ever done was saying goodbye to my young children. We had prepared them for this day. Personally, I didn't know if I was going to survive or not. Luckily, everything went according to plan, and I spent 10 days in the hospital before I could go home to my family. Today, I wear my scar with pride, but it's not what defines me. I'm a mother, wife, daughter, sister, friend, and colleague first. Somewhere after that, I'm also someone who's gone through a life-changing experience, and who wouldn't be here if it wasn't for someone else's unselfish decision to donate their organ. I feel that I have an obligation towards my donor to live my life to the fullest. What would be the point of my life if I didn't?
Thank you, Fredrika. A few words on our trends. The key market trends in our industry which we want to share with you. We start with the perfusion machines or machine perfusion and solutions which allow for the utilization of more marginal organs, including organs from non-heart beating donors, which we normally refer to as DCD donors. This creates a large untapped pool of potential donors. Political ambitions. Addressing organ shortage is a collective effort from public and private sector, and we are welcoming increased support from policymakers, making it easier for our customers to use machine perfusion, such as the Association of Organ Procurement Organizations in the USA, driving initiatives within the research community to reach the goal of at least 50,000 transplants by 2026. Services.
The acquisition of STAR Teams in the U.S. and Avionord in Italy helps to remove important hurdles from the transplant team when it comes to organ recovery, logistics and perfusion services. We will talk more about this later. Digitalization. We see a demand in the market for more data-driven tools, and we are currently running a pilot with the world-leading Cleveland Clinic on our XPS device for lungs to create a better foundation for decision-making when it comes to utilization of marginal organs. Xenotransplantation, potential method for addressing donor shortage.
So far, the only successful attempts have actually been made possible because of our revolutionary heart technology. Two leading centers, Munich and Maryland, have both asked us to guarantee delivery of our unique heart technology and solutions as their research completely relies on us. I will now talk a little bit about our 2023-2027 strategy.
Important to start with what we have actually achieved over the last 12 months. Just to give you some examples, we have the launch of Kidney Assist Transport after the 510(k) clearance. We have had a very strong double-digit growth over the last 12 months. We are continuing to invest in clinical R&D and commercial. Strong progress in heart trials, Europe, Australia, New Zealand. You will hear more about this later. Completion of 2 acquisitions since last year, STAR Teams and Avionord machine and perfusion services. When it comes to the new strategy period, we have updated and sharpened some of the strategic objective or the 5 strategic objectives. What we last year called Global Leader Abdominal with initial focus U.S., is now called Market Leader Abdominal.
We have already launched in the U.S., and we're now preparing for the European launch of Kidney Assist Transport early next year. We have, as you have seen yesterday, been granted Breakthrough Device designation from the U.S. Food and Drug Administration, the FDA, for our Liver Assist device, which is fantastic news. We are planning to start the clinical trials as soon as possible in the U.S. During the clinical trial period, we will actually create revenue since we can charge the trial sites for the products consumed. Market-leading heart preservation system becomes changing the paradigm of heart preservation. We know that our heart technology enables more hearts to be transplanted as out-of-body times increases significantly. This means, of course, a complete change in the paradigm of heart preservation. More about this later.
Increasing penetration of machine perfusion now is labeled preferred partner in the transplant process. Organ transplant starts with organ recovery and ends with the actual transplant and post-transplant follow-up. Machine perfusion and our fluids or solutions are key for successful outcome. We want to stress the importance of the full ecosystem. Recovery, logistics, perfusion services, et cetera, are all important ingredients for the full transplant process. Securing all-inclusive reimbursement in geographies becomes accelerating market leadership lungs. Reimbursement is an important ingredient of all strategic objectives, actually, and therefore we have decided to add a strategic objective specifically for lungs. We are today global leader in lung preservation and evaluation, and we will speed up our growth ambition. China to become second-largest market now reads new market expansion.
China is important, but Brazil is today the second-largest abdominal transplant market in the world, and all our products are today registered in this very important market. Hence, increased focus on Brazil in addition to China. This is the leadership team that is actually driving the strategic agenda forward. One change that recently was made is that Christoffer Rosenblad, former Chief Operating Officer, is now responsible for the global business development agenda and also service director, and will lead our ambition to become the preferred partner in the transplant process. Last but not least, why invest in XVIVO? We are strengthening our leadership position in a growing market. Our products and services offer increased availability and utilization of organs. Our products are high-margin products and increasing margins, of course, translate into profitability.
We have a unique R&D portfolio with products ready to launch in the near future. We can fund our complete R&D portfolio without raising additional capital. You will hear more about the road to commercial launch of our heart technology, which is due to be launched starting Q1 2024. Now it is time to talk financials, and I hereby introduce my CFO, Kristoffer Nordström. Welcome to the stage.
Thank you, Dag. Yeah. Hi, everyone. My name is Kristoffer Nordström, and I am the CFO of XVIVO. It's a pleasure to talk to you here today. To build on to what Dag just mentioned about the XVIVO as a investment case, I would also like to emphasize four very strong key messages here about XVIVO as a company from a financial aspect. First of all, I mean, we are operating on a growing market. It's a billion-dollar market that is growing rapidly. The demand is 10% higher than the actual supply, right? We do also expect clear growth drivers these next few years. You will hear more about them from my colleagues, Christoffer Rosenblad and Johan Holmström during this presentation. We have been profitable since the very beginning.
Company started 2012, only Q1 of a negative EBITDA, and that was actually during the COVID outbreak, 2020. We will also have a laser focus on sharpening this profitability, as you will hear soon. Finally, as well, very important, we are well capitalized. We have a very healthy balance sheet that will support our future growth. If you look at the market for machine perfusion, and we showed this picture last year as well, it's a $1.3 billion market today. And as we speak now, the market is growing, right? Interesting and the kind of beauty, so to say, is that only 15% of this market potential is actually realized today. 85%, is out there for us to capture.
At XVIVO, we have products, and we also now have services to fully capture this fantastic potential. I mentioned growth drivers, and you will hear more about them in specifics very soon, but I also want to highlight the profitability. XVIVO as a company, I mean, we have invested a lot in highly innovative state-of-the-art products. That also makes us in a very good position of charging for our products, of course. We have had a very good development lately. The last two years, I mean, thoracic from 79%-83% in gross margin for disposables. Abdominal, even higher, better improvement, so from 50%-55%. This is mainly driven by our price increases, but also that we are growing on the right markets at the moment.
What's really good, this is what to expect, is that there will be some very tangible boosters to come. If you look at abdominal in specific, when we launch fully, so to say, our Kidney Assist Transport in the U.S., we're looking at a gross margin of above 70%. When we soon integrate Avionord to our Italian business, we can also expect margins up to 70% because Avionord has, in a very good way, showed the beauty of combining services with products. It's 25% of our abdominal market today, and we are, of course, eager to see how we can take this beautiful business model to other markets.
On top of this, we will also have our continued focus on price increases, and we will work hard on reimbursement on key geographies. I think we have said before, but worth mentioning, I mean, our target, especially for abdominal, is to see margins climbing up to the margins of our thoracic margins. We will do so during the strategy period. This has also led us to fine-tune and increase our profitability ambitions a little bit. Last year, we said that we should reach an EBIT of 20%, EBITDA of 30%. Now we can say with confidence that we will beat those targets. We will reach above 20% EBIT, 30% EBITDA during the strategy period.
This, of course, considers all our commercial efforts and also all our preclinical investments that we do in the organization. Capital structure. Even more important now as the environment is shaky out there and there is a lot of macro uncertainties in the world. We are very happy, and we have, I mean, we have driven this company in a very sound and healthy way, and we will continue to do that. We have no external funding at the moment, and we are having a good equity-to-assets ratio right. This means that we can, and we have the ambition to fully fund our future growth aspirations with our own cash flow.
To the last slide of this session, some key takeaways from Dag's presentation and mine to keep in mind. Our strategy, it builds on five strategic objectives. All of those will strengthen our core business, but they will also drive expansion of new products and markets.
We have a history of profitability, and we will continue that way, and we will even sharpen the core to our profitability, our gross margins on our products and services during the strategy period. Finally, we will have an operating cash flow that will fund our R&D agenda and also our commercial aspirations. Thank you. Good afternoon. In this session, I will spend some time on our machine perfusion strategy, the key drivers we have to further increase penetration of machine perfusion. Our machine perfusion strategy and the need to continue to drive increased penetration is the core of our economic engine, ultimately, how we want to increase our revenue per machine.
It also supports our key strategic objectives, so to become market leader for abdominal globally, to become the preferred partner in the transplant process, and not the least, how we can further accelerate our market leadership in lungs. This is the segment where we're already leading by far, but we know there's a lot of potential left. Over the past years, there's been quite a rapid growth of installed machine base. When we look back at 2019, we had 45 XPS machines for EVLP installed around the globe and 98 machines within the abdominal field. Since then, we had a little bit of a stagnant year in 2020 for many good reasons.
From the back end of 2021 and until to date, 2022, we actually have increased our installed base of machines by 35% for XPS and EVLP, so we now have 60 machines in clinical use around the world. For abdominal, it's an increase of 60%, 154 machines. Then we have just started to look at the U.S. market on the abdominal area. Quite a big uptake over the past two years and what we actually continue to foresee. While machine perfusion and what we see, , has gained full clinical acceptance, organ transplantation is still a very complex and highly specialized process. We also see that many centers are experiencing constraints in resources to recover, to preserve, and evaluate organs, also resources to manage transportation and logistics and so on.
From that, what has happened is that more and more service offerings are surfacing in the markets in the U.S., but also in Europe. Where service models are gaining acceptance in order to help customers to overcome these different hurdles. In our case, what we have done is, you heard from Dag previously, we've done two acquisitions. STAR in the U.S. Is placed into the area of recovery and logistics, and most recently, Avionord in Italy. Later on, you will hear some more from Christoffer talking more in-depth about this. For us, we see this as one of the drivers to further increase both value and penetration of machine perfusion, and likewise, , how we bring more retention and customer satisfaction.
Two of our most overriding commercial priorities is of course to increase revenue per machine. Jointly with that is also how we further accelerate our installed base of machines. Specifically maybe for abdominal, we see the acceleration of installed machine base as extra important, to put it like that. I will talk a little bit more about EVLP later here. Commercial excellence has always been, in the past two years, on our agenda, and we have actually doubled our commercial resources and efforts over the past two years, and we will continue to invest ahead of the curve, particularly in North America. In Europe today, we have actually the highest presence of all competitors in the market. We will continue to invest in Europe as well.
The coming year, there is a higher focus on North America to drive more resources for clinical expertise, clinical support, and professional education. When it comes to EVLP and XPS, 2022 has actually been a record year in building installed base of XPS machines. We also see that there is a lot of economies of scale and scope in order to be fully successful with EVLP. We see that very evidently from our largest customers and centers. What is also surfacing and something that we facilitate and support and drive is what we call organ hub models for EVLP. Basically, where you have centers driving EVLP for other centers. In that way, you get the scale, you get the economies and you get the scope. That's something that is quite successful today.
As a few examples of that, maybe our prime example is Lung Bioengineering in the U.S., who currently have two sites, I think, moving into a third site, who is doing, , providing lungs for other centers, running the EVLP process. Very successful. We also see similar with Cleveland Clinic, another very large customer and center, LifeShare of Oklahoma, and in Europe, similarly, several initiatives running and several initiatives that is going in this direction. And that will, of course, help us to further drive penetration of EVLP, where we have some very sharp objectives the coming years. To start up investments in machines and to start up transplantation programs is, of course, big investments for the centers.
We also recognize that, having flexible value propositions and pricing models with our customers, is a way of also driving penetration and also customer satisfaction and increased utilization. One thing that is more and more being applied, particularly for abdominal, is that we look rather at, a price per intervention. Where you have placement of machines, the volumes, and you can then support the utilization quite strongly also from a financial point of view. That also helps us to drive value in the different interventions that are happening and retention. When that is combined also with service models, like we do in Italy, we see an even further increase of penetration and value per intervention, along with an increased customer utilization.
This is proven to be a very strong model and something we will continue to drive going forward. Our ambition is that by end of 2027, we shall more than double our installed machine base, particularly for abdominal. Then for EVLP, we have the ambition of reaching more than 20% penetration. Currently today, in the world, globally, around 7%-8%. In the U.S., we're closer to 13%, growing fast, both in Europe on EVLP and also in North America. Of course, new products will continue to have focus for us and to create our growth and penetration. We recently launched our new Kidney Assist Transport in the U.S.
As we move into the coming quarter and beyond, we're actually accelerating that launch and going full force in the U.S. With Kidney Assist Transport. Entering into 2023, we start the launch process also in Europe and rest of world markets. We expect to see a continuous nice development of these products. Our groundbreaking technology for heart, which you will hear more about later on. Obviously, here we are now in a phase where we are preparing ourselves commercially, making sure we are ready for launch in Europe and Australia and New Zealand as the first markets out in Q1 2024. We are also in the phase of pre-market approval process in the U.S.
Jointly with the clinical trial, we see that we'll actually have a revenue-bringing trial in the U.S. for heart as well. Liver Assist and our Premarket Approval process in the U.S. that is also being initiated will also be run jointly with a revenue-generating clinical trial. Very exciting process that we're entering into right now. Last but not least, of course, XPS, the next generation of XPS 1.10 that we are planning to launch during the early part of the strategy period. New market expansion, which is one of our, I shouldn't say the last, but one of the five strategic objectives. The way we define that is that our core markets today is Europe, Western Europe and North America.
We will continue to drive those markets, of course, but we cannot neglect that we have a lot of new market opportunities, some which are moving very fast and are big markets. You heard a little bit from Dag on that. What we do is that we're gonna continue to build our position in China. We call it build it in a controlled and sustainable way. It's a huge market, huge potential. We need to make the right bets on what areas we will be in. Then in parallel, which we started last year, we are quite heavily increasing our focus on Latin America, and specifically Brazil. The second largest market for abdominal transplantation in the world today.
The good news is that we have started our presence, we have partners, we have people, and we are getting quite active in this market. Middle East and Africa, select markets, South Africa being one where we just have a new partner, and then in Saudi, where in Middle East, which is another focus market for us. We're looking at some select Asian markets like India, select markets in ASEAN part of the world. What we always do when we go for new markets, we have an intent to go with a full portfolio. Right now, for example, in Brazil, we have that. In China, we focus on lungs. But for the others, we try to go with full registrations. Today, sales outside the core markets are a relatively small part with rapid growth.
What we foresee is actually by 2027, we should have 15% of our global sales in new market, from new market expansion. Before I close, I would like to leave with three takeaways here. We will continue to see rapid growth, and increased penetration of machine perfusion in all our core markets. We're on a very strong journey right now. We will of course continue to focus on new product initiatives, Liver Assist in Europe and soon to come in U.S., so we're starting the process for U.S. Heart, of course, and an acceleration of Kidney Assist Transport. In parallel with launching services to drive further value growth of our business. As said, last but not least, 15% of our business should come from new markets by 2027. Thank you.
Welcome. You just got the opportunity to listen to our CCO, Johan Holmström, and the importance of service models to reduce hurdles for the transplant team. Beyond product helped to recover those hurdles. This section will deep dive into beyond product and our two recent acquisitions to remove those hurdles. We previously presented during Dag's and Johan's presentations that there are some key hurdles in the transplant process to adopt more machine perfusions and have better outcome in organ transplantation. They are mainly in logistics and capacity.
For us, that means that we need to remove those hurdles to become a preferred partner in the transplant process. During the last 12 months, we addressed those two issues with two acquisitions, and I will start briefly to talk about the two acquisitions and deep dive a little bit more into them and the impact for XVIVO.
The first acquisition is called STAR Teams. It's an organ procurement service that will simplify the organ recovery process in the U.S. The second acquisition that we press released this summer was Avionord Machine Perfusion. With those two acquisitions, we will fully cover the whole transplant process where XVIVO is present today. The situation is that today, many organs are lost, mainly due to lack of resources and lack of a clear process in the organ recovery process. STAR Teams has done a tremendous job in addressing this issue. One example I can take from real life, two weeks ago, I was there traveling with STAR Teams, and we went out for a heart.
When we arrived at the organ recovery center, we called the lung clinic and asked, "Should we take the lung as well?" They said, "Yes." We took the lung as well, flew the heart and the lung to the right recipient. By doing that, we simplified the process a whole lot. We could skip two flights, which are costly and energy consuming. Most importantly, we could reuse time that the surgeon team spent in the field when they should rather spend doing transplantations. A little bit more on the STAR Teams acquisition. To start with, it's aligned with our strategy. It ticks four out of our five boxes, as you can see here.
Also, more importantly, it's our first step, stepping stone into the service segment, which is important to remember. This is also high-growth business for us, so we will come back to that more. The second and most recent acquisition is of Avionord Machines and Perfusion. It is an Italian service company that supports clinics with perfusionists perfusing the organs with our machines. It should also be mentioned that Avionord has developed a very nice pricing model where we can price per procedure rather than a price per kit, which is very good on both sales and margins. Lastly, we should also mention that it drives penetration. We can see that we're active in 50 out of 22 liver transplant centers in Italy, and the penetration in those are between 20%-25%, which is amazing. This is really high.
If you listen to Johan before, it's a high number. With this model, we believe that we can reach that in more countries than Italy. Lastly, we should also mention that Italy is the biggest liver market. Part of the deal rationale was that we secure Italy. By securing Italy liver, we can also secure Europe going forward. We can also see that this acquisition has strong strategic rationale, and it will bring us one step closer to being a preferred partner in the transplantation process. I talked about service now. We have another leg in the beyond product portfolio, and that's the digital. We also believe that a digital offering will remove hurdle for the transplant team and will make us become a preferred partner in the transplantation process.
I won't spend a lot of time on this, but I would talk a little bit about our pilot with Cleveland Clinic. We just started a pilot to improve decision-making in the transplant process. Why did we do this? It's very simply to increase the confidence to use marginal and more lungs through predictive analysis. What we're gonna do is simply use XPS data to enable evidence-based decision making. Then by doing that, we could also support the hub model, which you see is a model within the service segment that is increasing. We choose to partner with Cleveland Clinic. The reason is that they are a world-leading clinic. They are today, I would say, the most advanced in predictive analysis and decision making. I'm very much looking forward to this.
To round off my part of the presentation, the key takeaways are that a beyond product, which is service and digital for us, it will increase penetration on machine perfusion, which means that machine perfusion will be used more using service model. Important for XVIVO is that both revenue and margins will improve, and as we have seen in Italy, quite dramatically, actually. Last but not least, and the most important reason for having a service there is that a service create customer satisfaction and customer retention, and that will be very important going forward for XVIVO. Thank you.
Time to market is important for every company, and especially in medical device industry. The development times are long, and also every day that passes without having a product registration also means a day when a patient can't get the benefit from a device. I often get the question as a regulatory person, "When can we expect a product launch? When do we have the registration certification?" One important thing to remember then is regulatory strategy. Is the fastest route to market always the best? Today the topic is what is a regulatory strategy, the importance to consider and navigate in a dynamic regulatory environment. Once we are in the main markets, Europe and U.S., what can we do to expand our business further?
The regulatory strategy helps R&D, clinical, trial design innovation to make the right decision to get to market with the best, offer and secures the further success of the product on the market. The pitfall is seeing the regulatory process only as a matter of number of tick boxes just to do, and not understand the importance to have seeing the bigger picture and how the regulatory strategy can help the company to maintain its competitive edge in the market. Earlier this week, XVIVO announced that we will pursue with a PMA route for Liver Assist in the U.S. What are the different options in the U.S. to get to the market? The options you have is based on risk, but also how many patients can benefit of the device.
One of the most common routes to the market is the 510(k) pathway. That route can be used when you have a low to medium risk product where there already are products on the market. What you do is to say that my product is substantially equivalent as a product already on the market. Therefore, you can't really do any claims that your product is innovative. By choosing the 510(k) route, FDA has already considered the risks, and they know what to expect from products out there, so they feel secure. The process is relatively fast, and fast in regulatory terms is maybe a year. FDA have around 100 days to review. It's their goal. You have 180 days when you get the questions. What else to consider?
Do I need clinical data to support? Well, even if the regulations haven't changed, it's higher demand on the quality of data submitted and also the clinical evidence. Even if you have a 510(k), we can see that more and more 510(k)s requires clinical data. In addition, if you can claim substantially equivalent on your device, it also gives your competitor the possibility to have a similar device on the market because your device will also become a substantially equivalent device. A similar pathway to the 510(k) is the De Novo route. That can be used when you have the similar risk level and the intended use of your device is almost the same as something on the market. For that pathway, you definitely need clinical data.
One thing is, that is important to remember is once you're there with your De Novo product and has passed the De Novo pathway is that your competitor can use your De Novo device as a predicate device. All of a sudden, they can go for the 510(k) route. For new products, innovative technologies, the PMA route is chosen. Also there, if they consider these devices with a high level of innovation, it's considered higher risk. The process is longer and more complex. Not only they are looking into product design, they're also looking at manufacturing sites, and it requires panel review meetings where you have clinicians involved voting for your device. Clinical data is definitely needed, but compared to the De Novo process, your product can never become a predicate device.
No one can just copy your technology and use your device as a predicate, which is good, of course. To conclude, XVIVO has chosen to pursue a PMA route to be able to leverage the full potential of the device and also raise the bars for the competitors because both the De Novo and the PMA route requires clinical data. Meanwhile, you start the clinical trials in the U.S., you establish the key opinion network, and you have a good start once you have the full PMA in place. The next thing to remember, besides the different options, is, as I mentioned, the dynamic regulatory environment. There are a lot of changes. One thing that you probably heard about is the new European Medical Device Regulation.
The Medical Device Regulation was approved and came into force in May 2017. The purpose is to increase patient safety, increase the level of evidence needed or the process, certification process, and raise the skills among notified bodies. The first directive, the regulations for medical devices in Europe, came in 1993, so therefore, the regulation needed modernization. For example, now we have a lot of software, we have nanomaterials. The healthcare itself has developed. Now transplantation, there are innovations in transplantation, so the regulation needs to be modernized. It has been a four-year transition period. From the beginning, it was three, one year delayed due to COVID. From the 26th of May 2021, it's not—no possibility to issue certificates under the old directive.
All old certificates needs to be transferred to the new MDR. For many companies, it's a huge burden. The regulatory process are longer and more burdensome, more complex, more focused on clinical data and post-market follow-up. It means that many companies, many products will disappear from the European market, and some companies will not make it or even try to make it. As of this summer, 15% of medical devices are certified under MDR, which means that 500,000 devices in Europe still needs to be certified, and it's only 20 months left before the deadline for 26th of May 2024. That means that notified bodies issuing the certificates, competent authorities, and also European Commission have a very high workload. That in turn means that regulatory processes will be sometimes very long.
Of course, this is very important to us, and we are well-prepared. The Kidney Assist Transport device got its MDR certification in March 2022, and we are on track with our full product range, and everything is arranged with our notified bodies. They were early adopters to the regulation, so they were designated early on. One of our strategic objectives are new market expansion. South America will focus on Brazil, China, and Middle East. What can we expect from the new market entry? All countries have their own regulation, which means that you need to have a registration process in each country. Clinical data from Europe and U.S. can often be utilized, especially in the transplantation industry. The CE certificate is often a prerequisite to start the registration process. What is the status today?
In Brazil, we have the full portfolio basically registered for lungs and abdominal. In China, we have the lung portfolio. The XPS is pending. We have had a panel review meeting with positive outcome. In Saudi Arabia, we have our lung portfolio registered. We are very, very well equipped to support the new market entry. To conclude this session, that we will proceed with the PMA route for our innovative technology, Liver Assist. We are well prepared and positioned for the MDR transition, and we have product registrations in place to support the new market strategy. Thank you.
Dear listeners, dear viewers, it's my pleasure to be here today to present XVIVO's heart preservation technology to you. Today, we are more confident than ever that our heart technology can be more than just market-leading. It's got the potential to become the standard of care in heart preservation and transplantation. The key activities for the coming years are trial completion in Europe and Australia, start of and inclusions in our U.S. trial, and the first clinical sales of an approved product in 2024. Already today, we have sales in compassionate use cases outside of the clinical trials. Surgeons that have once been exposed to this heart preservation technology finds it's instrumental to be able to achieve safe transplantations. Heart failure affects more than 60 million people globally, and the prevalence is rising.
At the final stages, life expectancy is as short as six-12 months, which is worse than many of the most aggressive cancers. For me, a 45-year-old man, my lifetime risk of developing or being diagnosed with heart failure is actually as high as 35%-40%. Transplantation is a life-saving treatment, but only available for a very small minority of patients that develops heart failure. The limiting factors for more patients, and benefiting from this, treatment is of course, the number of available donors. Even maybe more importantly, the percentage of donor hearts that can be utilized from those donors. Donor hearts slowly die in transport.
As demonstrated in this figure to your left, an ischemic time or transport time of a donor heart increasing from 3 to 6 hours implies an increased risk of mortality or death during the first year of more than 70%. Older and extended criteria, with that we mean high risk or risk factor donors, have an even higher risk since those hearts are more vulnerable to the ischemic injury caused by transport. To be able to increase the use of donor hearts, we must protect them from the injury during transport. Ice transport is still the gold or cold standard for majority of the donor hearts being transplanted today. One step up is temperature control. By this, we mean avoiding the freezing point. This is easily achieved with static devices.
These are simple and easy to copy products that will not still prevent ischemic injury of the heart. Neither will cold perfusion with a generic solution provide the essential oxygen that is needed for protecting of the donor heart. Organ injury can only be avoided by non-ischemic preservation. XVIVO's technology is doing just that. By continuously perfusing the organ with an oxygenated solution that is tailored just for this purpose, this non-ischemic state can be achieved. XVIVO has for 20+ years excelled in solutions and perfusion technologies. This is now implemented in the unique heart preservation technology. A warm, heart-beating perfusion system does not have a place in optimal heart preservation. It's complex to operate, it's bulky to transport, and it does not provide the organ safety that is induced by cold temperature.
More alarmingly, more than 20% of hearts perfused cannot be used for transplantation after perfusion. The long-term follow-up of the only randomized trial comparing the existing warm perfusion technology with ice is discouraging. It shows significantly worse survival for recipients of warmly perfused hearts. Even ice transport is better. Complexity, lack of safety, and risk of organ loss is everything that the XVIVO technology is not. This is instead continuous oxygenated cold perfusion with a proprietary solution. The device is easy to operate, and users typically needs two hours of training before being independent. The 8-degree temperature protects the organ in the unlikely event of a stop in perfusion.
Over the more than 100 clinical transplants performed in our studies, we have not had one heart lost due to device deficiency. XVIVO's novel heart preservation technology can increase utilization, especially in extended criteria donors.
It can improve outcomes, provide or allow for longer preservation times, and with that, longer travel distances and better matching between recipients and donors. Achieving all this will be cost-effective to the healthcare. The ongoing clinical trials not just gives us the data that we will utilize for the regulatory approvals, it also gives us direct access to more than 20 European and Australian trials. The testimonials from the users are that this technology is intuitive and easy to use. The surgeons comments and reflections are that the hearts that has when they are arriving after perfusion, they are softer, they are more active or alive, if you can say, and they spontaneously regain activity during a transplant.
What is the geographical market or addressable market rather? In Europe, the 15 trial sites together perform more than 600 heart transplants annually.
In addition, another 1,500 heart transplants is performed over Europe for every year. 2,100 heart transplant recipients every year. 40% of them have a donor heart that has been transported for more than four hours, and with that, they are exposed to the risk of morbidity and mortality that that means. The trial sites, they express strong interest in post-trial use for long transports. For extended criteria donors and also some potentially for standard donors. Being a trusted partner in transplantation puts us in a unique position to introduce the heart technology and get traction already from day one after the regulatory approval that we expect in Q1 2024. With that, I would like to introduce my colleague, Jaya Tiwari, Vice President for Clinical and Regulatory Affairs in the U.S. Thank you.
Thank you, Andreas. Good afternoon. Good morning to those of you further west. Thank you for taking some time out of your day to spend with us. As you heard in the previous presentations, our proprietary technology that revolutionizes the field of organ transplantation is the foundation of ex vivo. It is empowering our vision continually that nobody should die waiting for an organ. We continue to be at the forefront of market change, and this is especially relevant when we look at the current state of heart transplantation in the world's largest market, the United States. While the United States dominates the global market in overall transplant volume and value, it is continuously outpaced by the growing number of patients that are added to the transplant waiting lists nationwide.
Around 6.2 million Americans are living with heart failure today, and that number is estimated to skyrocket to well over 8 million by the year 2030. In order to better understand the immense potential of the U.S. heart transplant market, it is essential for us to recognize what makes it so unique. When you look at the average age of heart donors in the United States as compared to Europe, you can see that the overwhelming majority of heart transplants performed in the U.S. come from donors under the age of 40, with as little as 2% coming from those aged 55 and older. In fact, just yesterday, a set of guidelines was published in the prestigious The Journal of Heart and Lung Transplantation with a primary recommendation for donors under the age of 45.
This is incredibly noteworthy as Americans are living longer lives with life expectancy continually increasing over the last century. As you can see, this is in stark contrast, whereas over half of donors in Europe are over the age of 40. Another significant difference can be seen in how far away transplant centers are traveling for donor hearts. A key measure that affects organ quality is ischemic time, which refers to the time that the organ is without blood flow. In other words, how long is the organ outside of the body? Approximately 80% of the United States transplants are from donors with an ischemic time under 4 hours. Whereas in Europe, donors with ischemic times of greater than 4 hours make up approximately 80%. I'm sorry, 40% of the transplant volume.
Now, in 2019, there was a significant change to the national allocation policy in the United States, mandating that transplant centers must travel further in order to procure hearts for their sickest patients. This is a significant reversal to the previous policy, which prioritized geographical proximity. Recent publications have shown that this change has had an immediate and significant impact on transplant centers where they are already traveling further distances. To put this in context, if we look at the year 2021, transplant programs and organ procurement organizations across the country achieved a record-breaking year of organ transplants with 3,817 heart transplants performed.
Yet, when you look at this group of patients who were able to receive a heart transplant compared to the total available donor pool, you can see it is almost triple in size, with over 8,000 organs being turned down for transplant. This presents a significant problem for transplant centers when the number of patients on the waiting list who need a new heart has increased 34% in the last decade. On top of this, individual transplant programs are reimbursed based on their outcomes, which fosters a risk-averse approach to organ selection. There is therefore a critical need by transplant centers to safely utilize organs that come from this untapped donor pool in order to perform more transplants and maintain good outcomes. This need is exacerbated by the growing number of patients in need of a new heart.
XVIVO's heart technology is uniquely developed to address this critical need by providing a protective environment for better preservation of the heart, which will enable transplant centers to safely use more organs. This is, as presented by Andreas previously, supported by the European and Australian clinical experience, which demonstrated that unlike normothermic technologies, the ex vivo technology and ease of use implemented safe fail-safe measures and can ensure transplant surgeons that grafts will not be damaged or discarded due to device malfunction or complexity of running the device. This is a key outcome measure that will be demonstrated in the U.S. clinical trial. XVIVO's heart product was the first heart perfusion device granted a breakthrough designation from the FDA.
This recognition is intended to facilitate review with the FDA and expedite the regulatory process for innovative technologies that may provide a benefit over what is commercially available. Following through on this designation, XVIVO has submitted an IDE application for a clinical trial with inclusion criteria specifically designed to evaluate and demonstrate the safety and efficacy of this technology on donor hearts from the market's greatest need, namely older donors, longer transport times, and extended criteria organs. We are working very closely with the FDA based on their previous experience with normothermic technologies to propose a better and more scientifically sound study that will generate high-fidelity data. The clinical trial, which has already garnered significant interest from transplant centers, will commence in 2023.
While XVIVO has sought approval from the FDA for up to 15 transplant centers for the trial, we have already received inquiries for participation from over 20 centers nationwide. Most notably, preparations are already underway with 4 of the highest volume centers listed here, who are led by renowned surgeons and who have participated in trials using normothermic perfusion. Their clinical guidance, enthusiasm for innovation, and experience with machine perfusion will ensure timely enrollment and successful completion of the U.S. Clinical trial. To conclude, there are several key initiatives underway to establish our global heart footprint. We are well-positioned to do this as we already are in over 90% of thoracic transplant centers worldwide through the use of our PERFADEX and PERFADEX Plus portfolios.
Our robust clinical trials programs is poised to secure regulatory approvals for almost the entire global market, with involvement in over 35 world-leading heart transplant centers, most notably including all heart transplant centers in Australia and New Zealand. To hear more about the Australian experience, I would like to introduce our next speaker, Professor David McGiffin from the Alfred Hospital in Melbourne, Australia, who is the lead investigator for the Australia and New Zealand clinical trials. Professor McGiffin, are you with us?
I am Jaya. Thank you. There we go. Jaya, can you hear me?
I can hear you. Thank you. The stage is yours.
Okay. Thanks, Jaya. Thanks very much. Thanks very much for the opportunity to talk to you about the Australian, New Zealand trial of hypothermic perfusion of donor hearts. As Andreas has already mentioned, we have a real problem in heart transplantation, and that is the injury that occurs to the donor heart. Firstly, because of brainstem death. It's the donor is a very hostile environment for the donor heart. Then we store the heart in ice slush, which we know is quite damaging to the heart. We've been doing that for the last 50 years of cardiac transplantation. The evidence is now accumulating that the longer we store the heart in ice slush, the greater the injury to the heart. We also damage the heart when we let it warm up during the transplant procedure.
Then when we reperfuse the heart, that is when we let recipient blood flow back into the, into the donor heart, we further exacerbate the injury that's already occurred from brain stem death and from cold static storage. It's not surprising we have a significant incidence of what's called primary graft dysfunction, which occurs after the transplant. That's the major driver of morbidity and mortality after cardiac transplantation. Why are we now looking at reactivating machine perfusion? There was a history of machine perfusion of donor hearts in the past. It never really got traction, but it does have significant traction now. Now, one of the reasons is because of the limitation in the allowable ischemic time. The ischemic time being that time that the heart is outside of the body, that is, it's not receiving blood supply.
Andreas has already shown this depiction. On the horizontal axis is increasing ischemic time. On the vertical axis in this depiction is the increased risk of death within a year. As the ischemic time increases, the risk of mortality increases, which is driven by this phenomenon of primary graft dysfunction. Now, no ischemic time is completely safe. As a general rule of thumb, a so-called safe ischemic time for a 20-year-old donor is about four-five hours, and a safe ischemic time for a 60-year-old donor is about two-three hours. Once you start trespassing beyond those ischemic times, then the risk of primary graft dysfunction, morbidity, and mortality substantially increases. Another reason for reactivating machine perfusion is the persistence of primary graft dysfunction as a major cause of death after cardiac transplantation.
This is a depiction from the International Society for Heart and Lung Transplantation, their registry. On the horizontal axis is years after transplantation. The vertical axis is the incidence of cause-specific death. The depiction I want to or the line I want to bring to your attention is the magenta line, the highest line, and that is the risk of graft failure. It's been that way for decades after transplantation. We're just not making any progress reducing that incidence. If we were able to eliminate primary graft dysfunction, then much of the morbidity and mortality of cardiac transplantation would absolutely disappear. Another reason for reactivating the idea of machine perfusion is the logistics of cardiac transplantation.
Why do we need to be doing cardiac transplantation in the middle of the night, which is inevitably what happens? It should be done as a daytime case, because that's when people are performing at their best, and all the resources are available, more likely to be available during the daytime than they are at nighttime to deal with very difficult clinical problems. My group's been investigating hypothermic machine perfusion for the last four years in Brisbane. We've been studying the damaging effects of brain death and static cold storage in a sheep model of brain death and transplantation. We've been using hypothermic machine perfusion to extend the safe ischemic times well beyond what we would normally think is safe in human heart transplantation.
It's been based at the Medical Engineering Research Facility in Brisbane as a collaboration of the Alfred Hospital in Melbourne and the Critical Care Research Group in Brisbane. I'm gonna play a video. Play the video, please. So this is a donor heart from a sheep, that's been transplanted into a recipient and has absolutely normal function. It was perfused on a perfusion system for eight hours with an ischemic time of nine hours and 45 minutes, well beyond what we'd ever consider safe in human heart transplantation. There it is with absolutely normal function. We saw this routinely in every sheep transplant we did that was machine perfused.
That gave us the confidence then to proceed with the Australian and New Zealand trial of extended ischemic time that is out to six-eight hours, well beyond what we would normally consider safe with cold static storage using hypothermic machine perfusion. That is the XVIVO heart box, which of course is the centerpiece of the trial. The principal investigators were myself and Professor David Kaye, the head of cardiology at the Alfred in Melbourne. Associate investigators were Professor John Fraser as the head of the CCRG in Brisbane. Christina Kure, who is the trial manager. The sponsor was Alfred Health. The financial and in-kind support came from XVIVO, and the participating sites were the Alfred in Melbourne, St.
Vincent's Hospital Sydney, Fiona Stanley Hospital, Perth, The Royal Children's Hospital in Melbourne, and Auckland City Hospital in Auckland. The overview of the trial is, the aim is to evaluate the effect of 6-8 hours of ischemic time of hypothermic machine perfusion on the function of the heart over 12 months after cardiac transplantation. We had a bit of a power failure. The philosophical underpinnings of the trial is that it's a non-randomized, single-arm, multi-center trial because we absolutely would not randomize patients for six-eight hours of ischemic time to cold static storage, which would be absolutely unethical. The sample size were 10 standard machine perfusion using the XHB, where the projected ischemic time is less than six hours, and that is the study running phase.
When each center has done 2 of these short ischemic time cases, they move to the extended machine perfusion where the projected ischemic time is greater than 6 hours for a total of 36 patients. Run the video, please. This is an example of a heart being placed on the XHB. This is a human donor heart. Is that video running?
Yes, it is running.
Okay, good. Thanks.
He's still using the trolley, so I can't move it from him. No. For sure. Yeah. I think that's much for me. Oh, no. Alex was gonna try and use it.
Here's a human donor heart now being connected to the system.
Okay.
Next video. Thanks.
Okay.
Run the video, please. Once the lid of the XHB is closed in the donor hospital, it does not need to be opened until you're in the recipient hospital. Then you can see on the right panel the XHB is just tucked between seats on the corporate jet. Here's an example. For those that aren't familiar with the geographical challenges we have in Australia, here's a case where the procurement occurred in Hobart, and the heart was then taken to Perth. That distance is 3,000 kilometers. That's the same distance as from Reykjavik, Iceland, to Istanbul.
We have a huge geographical problem of getting hearts, donor hearts from the East Coast to the West Coast and vice versa, and also from New Zealand to Australia. That's why this is. Run the video, please. This is why this is such an important technology in a country. Here's the XHB being taken off the corporate jet in Perth. You'll see how incredibly portable this is. That's one of the really highly desirable features of the technology. Run the video. Then here's the donor heart being taken off the XHB in the recipient hospital.
4 hours and 35. About 5 hours. Yeah.
Here's a human heart coming off the XHB. As Andreas had mentioned, these hearts feel very, very different from what we normally see with cold static stored hearts. They're very, very soft. Run the video. Now, I know none of you are used to interpreting echocardiograms, but this is an echocardiogram of that heart after an ischemic time of 7 hours and 30 minutes. That is a very well-functioning heart, something we would never see with the traditional preservation with cold static storage. Where are we with the Australian-New Zealand trial? Well, we had very considerable disruption due to COVID because Australia, as , was locked down. We couldn't move between states. We couldn't move between Australia and New Zealand. Training became a very significant problem.
If we didn't have COVID, we would have finished this trial about a year ago. We've done 31 cases of the planned 36 cases. There's been no mortality. The ischemic times, the longest ischemic time we've had is 8 hours and 47 minutes, which would be absolutely inconceivable with cold static storage. We've had one primary graft dysfunction requiring ECMO with full recovery. We've had two cases of secondary graft dysfunction where there was a very specific identifiable reason why the graft was dysfunctional, both requiring ECMO but both with full recovery. We've had short ICU stays. We've had no XHB-related adverse events. That is, there's been no graft loss. No heart has been lost on the system. We did a sample size calculation when we'd reached 20 cases, and this was based on historic transplant data.
That is, the probability of you ending up on mechanical circulatory support after an ischemic time of six hours using cold static storage. We could have truncated the trial back when we had 20 cases. That's how compelling the data is. We have had discussions with Qantas, the Australian airline, about sending the XHB on scheduled airline flights rather than on corporate jets. It's not going to happen on this trial because Qantas have had a lot of trouble recovering from their shutdown during COVID. It's something that Qantas is very interested in being involved with. What's the trial done to the practice of heart transplantation in Australia and New Zealand? Firstly, there is no donor heart in Australia or New Zealand that now cannot be transported to a transplant center.
Very, very different from before the trial, where we would be very reluctant to go to New Zealand for a heart, where New Zealand wouldn't come to Australia for a heart, where we wouldn't go from the East Coast to the West Coast and vice versa. It's completely changed the practice of cardiac transplantation in Australia. Now hearts are being taken from all over Australia. New Zealand's come to Australia. Australia's gone to New Zealand. Very different from how it was before the trial. The incidence of primary graft dysfunction after cardiac transplantation for trial patients has almost disappeared, despite these very, very long ischemic times. That's sort of revolutionary. The transplant community in Australia and New Zealand have embraced the technology.
The prevailing view is now that doing a long ischemic time case in Australia and New Zealand without the XHB is unethical. It's the Australian and New Zealand cardiac transplant community are united in their belief that this is going to change the face of cardiac transplantation. Thanks very much.
Thank you, Professor McGiffin, for that very compelling, talk. Please stay with us now as we transition to the summary of today's event and the question and answer session.
Yes, now we are actually coming to the final section or session of the Capital Markets Day. First of all, I would like to thank everyone for participating from XVIVO side and also Professor McGiffin. Sorry for the technical issues. That sometimes happens when we are having someone joining us from down under. We should take into consideration that it was in the middle of the night, so I'm really grateful for his participation and support. What I would like to do before we start the Q&A session is just to summarize the quantitative measures and targets that have been discussed during the presentations. As I said early on in my presentation, we would give you more quantitative targets than we did last year.
To summarize, we have committed ourselves to delivering at least 30% EBITDA by 2027, at least 20% EBIT by 2027. We have also committed to delivering at least 70% gross margin on the abdominal portfolio, meaning, liver and kidney. Johan Holmström, my commercial director, has also promised that there will be two times the number of installed machines in 2027 compared with this year. We will have also an increased penetration of XVIVO lung perfusion from current penetration level to 20%, even at least actually by 2027. 15% of global sales will come from new markets, meaning Brazil, China, Middle East Africa, and selected Asian markets. These are the quantitative targets that we commit to this year. Thank you all for listening to us, and now it is actually time for Q&A.
Telephone lines and chat function is open.
Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. Can we kindly request that you limit your questions to two? The first question comes from the line of Ulrik Trattner from Carnegie. Please go ahead.
Thank you very much, and thank you for this nicely hosted Capital Markets Day. Always have a lot of questions. I promise to limit myself to two. Hopefully, Dr. McGiffin is still on the line. I thought I was particularly interested-
Ulrik, he's on the line.
Oh, that's beautiful. It was very interesting to hear his reflections on the HeartBox. Just one question on Dr. McGiffin's thoughts. Once finalized in this study, and you're talking about this being unethical to be used for a longer transportation where you have prolonged ischemic times. Would you also use the HeartBox for shorter transports just to avoid any risk of primary graft dysfunction?
Professor McGiffin will answer this question. Yes.
That's actually a very insightful question. Our feeling is that perhaps the HeartBox should be used for possibly all heart transplants, except perhaps in the situation where the donor is in an adjoining operating room to the recipient, where the ischemic time would be extremely short, where the risk of primary graft dysfunction would be very, very low. Because we're—you're also balancing the cost of the technology. But primary graft dysfunction is unpredictable, and there are cases with short ischemic times, with ideal donors, where you'd never expect primary graft dysfunction, but yet it can occur for reasons that we don't understand. I think it's our sense is, and mind you, this is just a sense.
We don't have the evidence for it, but a sense that we could eliminate that unpredictable occurrence of primary graft dysfunction with short ischemic times. That's a long-winded way of saying, yes, we think that except for extremely short ischemic time cases, all hearts should go on the XHB.
Great. Thank you very much. Very insightful. I only have one question left then. I will take perhaps the more boring part of things and just look at. You have these ambitious financial targets. Last few quarters have been looking great, but now we're entering a different type of macroeconomic environment. I would just like to get your thoughts, Dag, on how you're seeing the current sort of CapEx cycles and the availability or the possibility for hospitals to buy into these new equipment. Perhaps if it were to focus on Europe, is there any risk that we could see that the new macro environment creates some limitation in introducing reimbursement for XPS?
It's a good question, Ulrik, and I think we have all been surprised by the macroeconomic development over the last six to nine months and things are definitely macroeconomically moving in the wrong direction. I think we are dealing with. I was actually talking exactly about this earlier today, Ulrik, and I think my view and my take on it is that I don't see any real impact on our business performance coming from the macroeconomic situation. I think a pandemic is impacting us much more than, let's say, a change or negative change in the macroeconomic climate. My assumption and view is that it does not impact us.
I mean, the only where I see an impact is on the cost, let's say, of supplying products or components. We actually took the decision to start price increases earlier this year. In the U.S., we have started price increases already from September first to make sure that we cover for any possible, let's say, increases in the cost in the supply chain. From a macroeconomic perspective, I think we are in an industry which is so important, . It's about life and death when it comes, , transplantation. I don't see that in itself having a negative impact on XVIVO. Hopefully, that answered your question, Ulrik.
Yes, it did. Thanks for a nicely hosted Capital Markets Day.
Thank you, Ulrik.
The next question comes from the line of Peter Östling from Pareto Securities. Please go ahead.
Okay. Thank you very much. A couple of quick ones around the well, the semi-new financial targets. Previously you had 20% and 30% EBIT and EBIT margin, now in 2026, and now you said at least the same kind of margins during the period. I interpreted that it's highly possible that you will reach those ambitions during well, within this period, not at the end of this period, but you're probably aiming at material being above those levels at the end of this strategy period. Is that correct?
I mean, Peter, I can only answer once again what is written here, and that is that we are committing ourselves to more than 30% EBIT by 2027. What that means for 2023, 2024, 2025, and 2026, I cannot today stand here and give any promise. I think the positive thing here is that we see that, , we see that we are improving our profitability. , the margins are increasing. We therefore would like to become a little bit more bold when it comes to 2027 by saying more than 30% EBIT, more than 20% EBIT, and then adding these other quantitative measures as well. I hope that is sort of positively perceived, Peter, but I cannot really make any additional comment on your question right now.
Okay. Maybe I read too much into the word during the period and not by.
Could be so, Peter, that you read too much into that. Yes.
Okay. When do you feel you will be ready to issue a top-line goal as well?
Yeah, that's a good question. We were actually talking about it for this year. It will come at some point in time. There is so much going on. I mean, we have the Kidney Assist Transport launch right now, , where we start in the U.S., now moving to Europe. We have the commercial planning for heart. We are getting closer to launching heart as well. We will eventually give you top-line guidance, but it was too early to do it this year. Whether it would be next year or the year after, I cannot comment on today.
Okay. What do you see during this period, 2023-2027, the critical components to reach your profitability ambitions? Do you see a gradual improvement that is very much hinged on the success of the Heart Box and the XPS? How do you view the different kind of existing and launching products during this period contributing to the overall profitability?
No, I think it's a combination. I mean, as you can see here on the targets, I mean, we are talking about a sharp increase in penetration of EVLP, for example. I mean, we are coming from, , low penetration, I mean, single-digit penetration to at least 20% by 2027. That is. That I think is an important, , milestone to achieve, , what we want to do in the future. Of course, you have exciting new technology. I mean, we have Kidney Assist Transport, which we believe will be hugely successful. I mean, kidney is the most transplanted organ. 64% of all transplants are kidney transplants in the world, and we have the best technology in the world. We know that. I believe very much in that technology.
Of course, heart. We are getting closer now to commercializing heart. You heard from Professor McGiffin how much he believes in that technology. Of course, part of our, , future success will also come from heart, no doubt. We have Liver Assist, which is already doing very well in Europe and some other countries around the world. Now we are, , starting the clinical trials. It's a combination of existing and new products and new regulatory sort of approvals that will give us the commercial success here, Peter.
Okay. Finally, before I jump into the queue, you said that you and we've seen that with some other companies also that you are able to get some revenues during the trials.
Yes.
Both for the liver and hearts.
Yes.
Just to remind me, when you get those payments, are they payments as if it were commercial products or is it 50% of what you normally would get, or how does it work?
I mean, it's not a full market price that we get, but we get a good enough price to make, , good money on it. We know more or less what we would be able to charge for liver disposables. Also when it comes to heart, for example, I mean, we have already had a few cases in Australia of hearts of our Heart Box used for, , compassionate use, where we have been able to charge money, Peter. You will see more of that next year also from both heart and from liver, as we also start the clinical trials in the U.S. for heart and liver.
Part of the revenue increase will come from, , these new product lines and or. Let's say the PMA process for liver in the U.S. and it will be good money, but not the full market price, no.
Okay, great. Thank you, Dag and team and external speakers for a very interesting set of presentations.
Thank you, Peter, for good questions.
Once again, ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. The next question comes from the line of Arvid Necander from Carnegie. Please go ahead.
Hello, and thanks for taking my question. Just one more question from the Carnegie team. I understand that you're intending to launch an updated version of the XPS. Could you just provide some more color on this? What changes or new features have you implemented in the new model and how much of an edge will this give you compared to competing products?
That is a very good question, actually, and I will invite my Global Head of R&D, Charlotte Walldal, to answer that question. Charlotte, come up on stage.
Well, hello. Yes, that's a very nice question. The aim of the upgrade of the XPS is to increase the ease of handling the machine. We will improve the look of the GUI. GUI is the screen where you find all the different data. It will be modernized, and will also be easier to access the data. We will also introduce another feature that will simplify the handling of the machine. Today, you have to lift up and down a reservoir to change the pressure, and we will, moving forward, have that done automatically. Basically these are the most important changes that we will have with the new XPS machine. Thank you.
Thank you, Charlotte.
Thank you so much.
Hopefully that was a good answer.
If I may just a quick follow-up.
Yes, of course.
Yeah, absolutely. Just on the uniqueness sort of. Are these features that would be unique to the XPS or-
That is.
How does it compare to the competing products?
Yeah, yeah. These are unique. I mean, the XPS in itself is a unique machine.
Fair enough. Okay. Thank you so much for
Yeah.
Thank you, everyone.
Thank you.
We have a follow-up question from the line of Peter Östling from Pareto Securities. Please go ahead.
Yes, thank you. A couple of questions on the Liver Assist. Dag, what was the key determinant factor to go with the existing product, the Liver Assist that you have in Europe versus maybe acquiring an entry ticket into the U.S. market?
I was actually expecting that question to come, and I'm happy for that. I mean, one thing doesn't exclude the other, Peter. I mean, we know that we have a fantastic technology that works in Europe and other parts of the world, and we know that it will work also in the U.S. Having said that, we know that it takes a couple of years to drive the PMA process forward. We are constantly looking at what are the other alternatives to let's say bridge the gap also in terms of do we want to wait a couple of years or do we want to do something a little bit quicker when it comes to delivering the U.S.?
This is something we are discussing and debating in the management team, , during our sessions and meetings. The issue we have is that we know that we have good technology. I mean, if you look at our liver technology, it's, , easy to use compared with, , the competitors that we have in the U.S., for example. I would say that our device and technology is absolutely, it's great. It's always a discussion of, , how long time are we prepared to wait to reach a certain position in liver in the U.S., and that might lead to us, , continuing to have discussions around acquisitions as complement to the PMA study.
We are starting the PMA process, or we have started the PMA process for liver in the U.S. with our device.
Great. You may partly have answered my next question already. I mean, your main competitor will have been on the market for maybe around four years, something like that. If you stay with, stick with the Liver Assist and run the full PMA process, what do you see the main feature that you will compete with TransMedics existing offering, if you compare them deliberately. You mentioned the ease of use. Is there any other features that you would highlight that when you maybe talk to potential customers or existing customers?
I mean, if you look back at what was published in the New England Journal of Medicine in, was it February 2021. If you look at our technology, which is, , it's a perfusion, hypothermic perfusion technology for liver, and we know that we have a great technology. As , our competitors are using, , normothermic technology in the U.S. We believe in our technology. It's a device which is easy to use. It is actually, if you look at the size, the time it takes to train someone to use the device, et cetera, we believe that we have some unique advantages there, absolutely. We believe in our device. We do.
Just finally, as I understand it, the Liver Assist and the Kidney Assist that you have in Europe could potentially be used both for normothermic and hypothermic perfusion. I guess that you have chosen the route now with this NMP study and all that you will go for the hypothermic perfusion route and not, for instance, leave open the possibility to use the Liver Assist also for normothermic perfusion.
I mean, we are right now designing the study together with FDA, so it is a little bit too early to comment exactly on how we are planning the study. We know that hypothermia has worked well with Liver Assist. We will come back to that once we are starting the study, Peter, and then there will be more information on exactly what we are sort of aiming for in that.
Okay, fair enough. Thank you, Dag.
Thank you, Peter.
We have another follow-up question from the line of Ulrik Trattner from Carnegie. Please go ahead.
Thank you very much. I would like to address STAR Teams and Avionord. These quite recent acquisitions seem also quite similar since they're in the service business. My question would be then, is this a start of a new strategic initiative for forward integration on your end? Just, we saw Christopher talk about how well that has developed in terms of penetration in Italy. Could that be replicated to other markets? Is there other opportunities in the service segments which you can exploit? Just how important is that segment in order for you to derive your 20% penetration in lung and double the installed base for the abdominal segment?
Fair question, Ulrik. I would actually ask Christoffer to answer that question since Christoffer is now the global head of service development and business development as well. Christoffer, you may answer the question.
Thank you. Thank you, Ulrik. It's a very, very good question. I like it. To start with, I think that we will be able to reach the 20% penetration EVLP both with and without the service segment. However, I think it will help a lot. It will help with the hub model. It will support the hub model over time. I think also that if we look at the Italian example, if we can export that revenue model to more markets, it will be very helpful in penetration, where we could see to comparable market in Europe that we have maybe a five-fold penetration with a service model where we actually help the customers with the perfusion step. This is mainly due to the lack of resources in transplant teams.
I do believe that it will be a great help to drive penetration of machine perfusion beyond what we think is possible today. Did that answer your question enough, Ulrik?
Yeah, sure. Just essentially, if you were to expand the service operations just in Europe through additional countries, then you would essentially need to revise your financial targets, given what we have seen in terms of five times penetration when you have a perfusion service installed in one country.
Yeah, we are under conditions precedent with Italian purchase right now. We will come back with an answer to that question after we have actually gotten access to the full company. In essence, yes, there are opportunities here beyond what we know today. I'm convinced of that.
Great. Since you're already up on stage, I think you can address my second question, and that would be on the digitalization that you're currently seeing in the field of transplantation. Can you talk about this sort of new projects with Cleveland Clinic to sort of harmonize the workflow. Could you just walk us through what it exactly entails in terms of what that enables in the future, as well as you have an ongoing collaboration with UMC Groningen for the abdominal area and in Europe, how is that progressing and is there any similarity between these two?
To answer the last question first, yes, there are similarities to it. It's all both have to do with a simplified decision-making where you should be able to accept an organ remotely based on a number of parameters. So they do aim at the same goal. We believe, as Johan told you earlier, that one part of our strategy is hub models. To facilitate hub models, you also have to facilitate the decision-making process for when you perfuse an organ at one place and you actually take the decision for transplant at a second place, could be many miles or kilometers away. To do that, we have to support the clinics with quantifiable data for, let's say, go or no-go of an organ and we see that.
When we co-travel with STAR, we can see that happen today on a manual basis where we film the organs, we show them, et cetera. We try to quantify it. Today there is no, let's say, accepted quantifiable data matrix on the market that could simplify decision-making. I would say that part, which organ should go to machine perfusion, which organ should use after machine perfusion, is probably one of the biggest hurdle we see today due to or for increased penetration. If we can solve those two issues, I'm pretty sure together with the resource issue, I'm pretty sure we can see increased penetration in the years to come.
Great. Thank you very much, Christoffer. Perhaps I could squeeze one question in for Dag here as well.
Thank you.
When I'm looking at your geographical expansion, China, South America and Brazil and Saudi, it sounds quite familiar on my end from your previous employer at Vitrolife. What experience are you bringing with you in expanding in these geographical markets, handling reimbursement and establishing a new operation?
Good question, Ulrik. I mean, I have worked extensively in all these markets and established very successful businesses in all these markets. I believe very much in Brazil. I've done very well both in my previous company and also in Lundbeck before that. Brazil is a large market. It's the second biggest private insurance market in the world after the U.S. There is money to be made in Brazil. , yes, there is reimbursement, but it's also partly paid by the private insurance funds or companies, depending on who, if the patient has an insurance or not. I mean, Saudi is a country which has a lot of money to invest in healthcare, and they have been investing extensively in healthcare over the last ten years, I would say.
That will continue. It's one of the fastest-growing populations in the world as well. I believe personally very much in Saudi, and there is a need for organs in Saudi. We know that obesity is a huge issue in Saudi, so I can just guess that the need for kidney transplant is going to increase at a very fast rate. Then, of course, China being the biggest market in the world in terms of, , the biggest population, largest population in the world, and they will become the biggest transplant market in the world eventually. In China, it takes time to register products. I mean, we have the lung products under registration right now.
We have registered PERFADEX Plus, and we are getting close to having the XPS registered. Abdominal product will take a little bit longer time in China. We see that Brazil and Saudi and a few other countries will be quicker, Ulrik, to penetrate. With the ambition of 50% of global sales coming from new markets, we have to explore these opportunities, and they're Brazil and China, and Saudi, sorry, will, I think, play very important roles.
Great. Just one quick follow-up question on that. I know that regulatory approval in China is kind of a black box, but could you give us your thoughts or any idea on when to expect the XPS to be approved in China?
I will ask our global head of RAQA, Katrin, to come up on stage.
Yes. It sounds that you are familiar with the black box phenomena in China. We have worked on this registration for quite a long time, but we see the light in the tunnel. We had a positive panel review meeting where clinicians were on the call, on the meeting, on the panel, and said, "Yes, it's an interest." We are now submitting to China according to new regulations. There have been quite a few updates, but I expect late this year or early next year. That's my best prognosis right now.
Great. Well, thank you very much again for taking my question and for hosting this CMD.
Thank you very much for excellent questions. There are some questions here that we are not able to answer today, and we will try our best to provide those answers when we publish, let's say, the material from the Capital Markets Day. There are a number of questions which have arrived here on the chat function here on Teams. We will come back and give as many answers as we can. I would like now to thank everyone for joining. I'm very happy that you all took the time. Thanks to the XVIVO management team. Maybe see you next year again. Thank you very much. Bye.